Pathologic complete response to cisplatin with dose-dense paclitaxel as neoadjuvant chemotherapy for locally advanced cervical cancer: Preliminary results of a multicenter phase II study with additional mutation analysis of adeno/adenosquamous carcinoma.

5528 Background: We report efficacy and safety of neoadjuvant cisplatin plus dose-dense paclitaxel (ddTP) within a phase II trial (UMIN-CTR ID: UMIN000006440), designed to investigate recurrence-free survival of neoadjuvant ddTP plus radical hysterectomy followed by adjuvant ddTP without radiotherapy for patients (pts) with stage IB2, IIA2, and IIB cervical cancer, whose driver mutations have been poorly understood. Methods: All enrolled pts received 3 cycles of cisplatin 75 mg/mq on day1 with paclitaxel 80 mg/mq on days 1, 8, and 15 every 21 days. Pathologic complete response (pCR) was defined as no evidence of malignancy in all surgical specimens observed. Using a selected panel of 535 oncogenes (Otogenetics, Norcross, GA), mutations of pretreatment biopsy tissues were analyzed in 6 non-pCR pts with adeno/adenosquamous carcinoma (AC/ASC). Results: Among 51 enrolled pts, 50 were evaluable (40 with squamous cell carcinoma [SCC], 9 with AC/ASC, and 1 with small cell carcinoma). Median age was 52 years (ran...